Prosthetic heart valve having flared outflow section

ABSTRACT

Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outward from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium, for example, porcine pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

RELATED APPLICATIONS

The present application is a continuation of Ser. No. 11/749,722, filedMay 16, 2007, which is a continuation of Ser. No. 10/653,843, now U.S.Pat. No. 7,276,084, filed Sep. 2, 2003, which is a continuation of Ser.No. 09/815,521, now U.S. Pat. No. 6,733,525, filed Mar. 23, 2001, allthe disclosures of which are incorporated by reference herein.

Field of the Invention

The present invention relates generally to medical devices andparticularly to expandable heart valve prostheses especially for use inminimally-invasive surgeries.

BACKGROUND OF THE INVENTION

Prosthetic heart valves are used to replace damaged or diseased heartvalves. In vertebrate animals, the heart is a hollow muscular organhaving four pumping chambers: the left and right atria and the left andright ventricles, each provided with its own one-way valve. The naturalheart valves are identified as the aortic, mitral (or bicuspid),tricuspid and pulmonary valves. Prosthetic heart valves can be used toreplace any of these naturally occurring valves, although repair orreplacement of the aortic or mitral valves is most common because theyreside in the left side of the heart where pressures are the greatest.

Where replacement of a heart valve is indicated, the dysfunctional valveis typically cut out and replaced with either a mechanical valve, or atissue valve. Tissue valves are often preferred over mechanical valvesbecause they typically do not require long-term treatment withanticoagulants. The most common tissue valves are constructed with wholeporcine (pig) valves, or with separate leaflets cut from bovine (cow)pericardium. Although so-called stentless valves, comprising a sectionof porcine aorta along with the valve, are available, the most widelyused valves include some form of stent or synthetic leaflet support.Typically, a wireform having alternating arcuate cusps and upstandingcommissures supports the leaflets within the valve, in combination withan annular stent and a sewing ring. The alternating cusps andcommissures mimic the natural contour of leaflet attachment.Importantly, the wireform provides continuous support for each leafletalong the cusp region so as to better simulate the natural supportstructure.

A conventional heart valve replacement surgery involves accessing theheart in the patient's thoracic cavity through a longitudinal incisionin the chest. For example, a median sternotomy requires cutting throughthe sternum and forcing the two opposing halves of the rib cage to bespread apart, allowing access to the thoracic cavity and heart within.The patient is then placed on cardiopulmonary bypass which involvesstopping the heart to permit access to the internal chambers. Such openheart surgery is particularly invasive and involves a lengthy anddifficult recovery period.

Some attempts have been made to enable less traumatic delivery andimplantation of prosthetic heart valves. For instance, U.S. Pat. No.4,056,854 to Boretos discloses a radially collapsible heart valvesecured to a circular spring stent that can be compressed for deliveryand expanded for securing in a valve position. Also, U.S. Pat. No.4,994,077 to Dobbin describes a disk-shaped heart valve that isconnected to a radially collapsible stent for minimally invasiveimplantation.

Recently, a great amount of research has been done to reduce the traumaand risk associated with conventional open heart valve replacementsurgery. In particular, the field of minimally invasive surgery (MIS)has exploded since the early to mid-1990s, with devices now beingavailable to enable valve replacements without opening the chest cavity.MIS heart valve replacement surgery still typically requires bypass, butthe excision of the native valve and implantation of the prostheticvalve are accomplished via elongated tubes or cannulas, with the help ofendoscopes and other such visualization techniques.

Some examples of more recent MIS heart valves are shown in U.S. Pat. No.5,411,552 to Anderson, et al., U.S. Pat. No. 5,980,570 to Simpson, U.S.Pat. No. 5,984,959 to Robertson, et al., PCT Publication No. 00/047139to Garrison, et al., and PCT Publication No. WO 99/334142 to Vesely.Although these and other such devices provide various ways forcollapsing, delivering, and then expanding a “heart valve” per se, noneof them disclose an optimum structure for tissue valves. For instance,the publication to Vesely shows a tissue leaflet structure of the priorart in FIG. 1, and an expandable inner frame of the invention havingstent posts in FIGS. 3A-3C. The leaflets are “mounted to the stent posts22 in a manner similar to that shown in FIG. 1.” Such generaldisclosures as in Vesely stop short of explaining how to construct avalve in a manner that maximizes long-term efficacy. In particular, themeans of attaching the leaflets to the MIS stent is critical to ensurethe integrity and durability of the valve once implanted. All of theprior art MIS valves are inadequate in this regard.

Another problem with MIS valves of the prior art is their relativelylarge radial dimension during implantation. That is, these valves allutilize one or more radially-expanding stents coupled to a biologicalvalve, and the assembly must be compressed radially and then passedthrough the lumen of a large bore catheter. Reducing the radial profileof the constricted valve via radial compression is problematic andconflicts with the need for sufficient circumferential length of thevalve in its expanded state to fit within an adult heart valve annulus.Moreover, radial compression of the stent and biological valve must bedone with great care so as not to damage the valve.

Some MIS valves of the prior art are intended to be used withoutremoving the natural valve leaflets. Sometimes the natural leaflets areheavily calcified, and their removal entails some risk of plaqueparticles being released in the bloodstream. Therefore some of the MISvalves are designed to expand outward within the annulus and nativeleaflets, and compress the leaflets against the annulus. In doing so, arelatively uneven surface against which the valve is expanded outward iscreated. This irregularity creates sizing problems, and also mayadversely affect the circularity of the expanded valve which negativelyaffects the valve efficacy by impairing leaflet coaptation.

Despite some advances in MIS valve design, there remains a need for avalve that can be constricted into a smaller package without damagingthe biological valve within, and which can be reliably expandedgenerally into a tube against the relatively uneven surface of theannulus or annulus and intact native leaflets.

SUMMARY OF THE INVENTION

The present invention provides an expandable prosthetic heart valve forplacement in a host heart valve annulus, comprising a stent body that isrolled into a compact configuration, implanted, then unrolled into atubular shape and secured into place in the valve annulus. The valve issmall enough in its contracted state to be passed down a delivery tube,thus avoiding the need for open heart surgery. Flexible membranes attacharound large apertures in the inner wall of the stent body and havesufficient play to billow inward into contact with one another and formthe one-way valve occluding surfaces. The stent may be one or twopieces, and the delivery and implantation may occur in one or two stepsusing one or two delivery tubes.

In a preferred embodiment, a prosthetic heart valve of the presentinvention suitable for minimally invasive delivery comprises a generallysheet-like stent body and a plurality of flexible, biocompatiblemembranes incorporated into the stent body to form heart valve leaflets.The stent body has a first, contracted configuration in which it isspirally-wound about an axis such that at least one winding of the stentbody surrounds another winding. The stent body further has a second,expanded configuration in which it is substantially unwound and at leastpartly forms a tube centered about the axis and sized to engage anannulus of a patient's heart valve. In accordance with one aspect, thestent body comprises a primary stent coupled to a secondary stent thatat least partially fits within the primary stent. The flexible,biocompatible membranes are incorporated into the secondary stent.Alternatively, the stent body is formed of a single stent.

The stent body may have a plurality of sinus apertures with an outeredge of each biocompatible membrane fastening around the edge of anaperture. The sinus apertures may be generally semi-circular orgenerally oval. The outer edge of each membrane is desirably folded overto contact an inner surface of the stent body adjacent an edge of theassociated aperture.

One embodiment of a heart valve of the present invention includes atleast one guide to insure concentricity of the sheet-like stent bodyabout the axis during a conversion between the first, contractedconfiguration to the second, expanded configuration. For example, thestent body may define a pair of opposed side edges that generally matein the second, expanded configuration, and a pair of opposed end edgesthat extend between the side edges, and the at least one guide comprisesa tab extending generally radially along each one of the end edges.Alternatively, the at least one guide comprises a tab extendinggenerally radially from the stent body and a cooperating slot in thestent body circumferentially spaced from and axially aligned with thetab. In the latter case, the tab enters and is retained within the slotduring the conversion between the first, contracted configuration to thesecond, expanded configuration.

In a further aspect of the present invention, the stent body defines apair of opposed side edges that generally mate in the second, expandedconfiguration, and the stent body further includes lockout structure toretain the opposed side edges in mating engagement. The lockoutstructure may comprises tabs formed adjacent one of the side edges andapertures formed adjacent the other of the side edges that are sized toreceive and retain the tabs. Desirably, the lockout structure bothprevents further expansion of the stent body and contraction from theexpanded tubular shape.

At least one anchoring barb may be provided extending radially outwardfrom the stent body in the second, expanded configuration. Where thestent body defines a pair of opposed side edges that generally mate inthe second, expanded configuration, and a pair of opposed end edges thatextend between the side edges, the anchoring barb extends from one ofthe end edges.

Preferably, the stent body is formed of a single stent having ananchoring section on an inflow end, a sinus section, and an outflowsection. The sinus section is between the anchoring section and outflowsection, and has apertures for receiving flexible biocompatiblemembranes that form the occluding surfaces of the valve. Eachbiocompatible membrane fastens around the edge of an aperture, whereinthe sinus apertures may be generally semi-circular and the outer edge ofeach membrane is folded over to contact an inner surface of the stentbody adjacent an edge of an aperture. The outflow section may flareoutward from the sinus section, and may include an apertured lattice,mesh or grid pattern.

The present invention further provides a method of prosthetic heartvalve implantation, comprising providing a prosthetic heart valve in aspirally-wound contracted configuration, delivering the prosthetic heartvalve in its contracted configuration through a delivery tube to a heartvalve annulus, and unfurling the prosthetic heart valve from itscontracted configuration to an expanded configuration that engages theheart valve annulus.

The prosthetic heart valve may comprise a single stent body having aplurality of flexible, biocompatible membranes incorporated therein thatform heart valve leaflets in the expanded configuration. Alternatively,the prosthetic heart valve comprises a two-piece stent body with aprimary stent and a secondary stent, wherein the steps of delivering andunfurling comprise delivering and unfurling the primary stent first andthen delivering and unfurling the secondary stent within the primarystent. The secondary stent may be guided into coupling position withinthe primary stent using one or more guidewires. The method further mayinclude anchoring the prosthetic heart valve in its expandedconfiguration to the heart valve annulus. If the native heart valveleaflets of the heart valve annulus are left in place, the step ofunfurling causes the prosthetic heart valve to contact and outwardlycompress the native leaflets. The step of unfurling further may includeensuring that the prosthetic heart valve remains generally concentricabout a single axis, and also locking the prosthetic heart valve in itsexpanded configuration.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary one-piece expandable heartvalve stent of the present invention;

FIG. 2A is a perspective view of an exemplary expandable heart valve ofthe present invention utilizing the stent of FIG. 1;

FIG. 2B is a cross-sectional view taken along line 2B-2B through oneside of the heart valve of FIG. 2A showing a preferred leafletattachment construction;

FIG. 2C is a perspective view of an alternative one-piece expandableheart valve stent of the present invention having a flared outflow end;

FIG. 3A is a perspective view of an exemplary two-piece expandable heartvalve stent of the present invention having oval-shaped sinus aperturesand leaflet attachment strips;

FIGS. 3B and 3C are end and side elevational views of the heart valvestent of FIG. 3A;

FIGS. 4A and 4B are alternative perspective views of an exemplaryprimary stent for use in an expandable heart valve of the presentinvention, particularly illustrating side tabs for alignment duringunrolling;

FIGS. 5A and 5B are alternative partial perspective views of a furtherprimary stent for use in an expandable heart valve of the presentinvention, particularly illustrating body tabs and slots for alignmentduring unrolling;

FIGS. 6A-6D are different perspective views of a further primary stentfor use in an expandable heart valve of the present invention;

FIG. 7 is a plan view of an exemplary secondary stent for use in anexpandable heart valve of the present invention, particularlyillustrating generally semi-circular sinus apertures circumscribed byleaflet attachment holes, and body tabs and slots for alignment duringunrolling;

FIG. 8 is a partial perspective view of a commissure/junction region ofan exemplary secondary stent, particularly illustrating side tabs foralignment during unrolling;

FIG. 9 is a perspective view of an exemplary expanded secondary stent ofthe present invention;

FIG. 10 is a perspective view of a primary stent like that shown in FIG.6A coupled to a secondary stent like that shown in FIG. 10;

FIGS. 11A-11C are different perspective views of a further exemplaryprimary stent having both edge and body barbs for use in an expandableheart valve of present invention;

FIGS. 11D and 11E are end and side elevational views of the heart valvestent of FIG. 11A;

FIG. 12 is a perspective view of a secondary stent coupled to a primarystent like that shown in FIG. 11A;

FIG. 13A is a perspective view of a schematic secondary stent beingcoupled to and unrolled within an expanded primary stent like that shownin FIG. 6A;

FIGS. 13B and 13C are detailed perspective views of the primary andsecondary stent coupling shown in FIG. 13A;

FIG. 14 is a schematic perspective view of an exemplary stent rollingapparatus of the present invention;

FIGS. 15A-15C are perspective views of the exemplary stent rollingapparatus illustrating details of first and second side edges of thestent;

FIG. 16 is a perspective view of an alternative means for securing asecond edge of a stent being rolled;

FIGS. 17A and 17B are schematic perspective views of a stent afterhaving been rolled in accordance with the present invention;

FIGS. 18A and 18B are schematic perspective views of a rolled stentbeing removed from a rolling mandrel;

FIG. 19 is a plan view of a still further one-piece expandable heartvalve stent of the present invention having a more solid outflowsection;

FIG. 20A is a plan view of another one-piece expandable heart valvestent of the present invention having a flared cage-like outflowsection;

FIG. 20B is a detailed perspective view of one end of a guide slot inthe heart valve stent of FIG. 20A;

FIG. 21A is a plan view of a heart valve having a one-piece expandablestent similar to that shown in FIG. 20A in several configurations from

FIGS. 21B and 21C are perspective views of the one-piece expandableheart stent of FIG. 21A in partially and fully unrolled configurations,respectively;

FIG. 22 is a schematic perspective view of a two-piece heart valve stentassembly prior to coupling a secondary stent to a primary stent usingguidewires; and

FIG. 23 is a schematic perspective view of a two-piece heart valve stentassembly prior to coupling a secondary stent having a wireform structureto a primary stent using guidewires.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention discloses a number of expandable heart valves forimplantation in a host annulus, or host tissue adjacent the annulus. Thevalves may be implanted in any of the four valve positions within theheart, but are more likely to be used in replacing the aortic or mitralvalves because of the more frequent need for such surgery in thesepositions. The patient may be placed on cardiopulmonary bypass or not,depending on the needs of the patient.

A number of expandable prosthetic heart valves are disclosed that areinitially rolled into a tight spiral to be passed through a catheter orother tube and then unfurled or unrolled at the implantation site,typically a valve annulus. The heart valves comprise one- or two-piecestent bodies with a plurality of leaflet-forming membranes incorporatedtherein. Various materials are suitable for the stent body, althoughcertain nickel-titanium alloys are preferred for their super-elasticityand biocompatibility. Likewise, various materials may be used as themembranes, including biological tissue such as bovine pericardium orsynthetic materials. It should also be noted that specific stent bodyconfigurations disclosed herein are not to be considered limiting, andvarious construction details may be modified within the scope of theinvention. For example, the number and configuration of lockout tabs (tobe described below) may be varied.

Those of skill in the art will recognize that the means and techniquesfor delivering and implanting the prosthetic heart valves disclosedherein are numerous and not the specific focus of the presentapplication. In general, the heart valves in a first, contractedconfiguration are delivered through a tube such as apercutaneously-placed catheter or shorter chest cannula and expelledfrom the end of the tube in the approximate implantation location. Theheart valve is then expanded via a balloon, mechanical means, orself-expanded from internal elastic forces, into a second, expandedconfiguration that engages the native host tissue, such as the targetvalve annulus. Depending on the native valve being replaced, theprosthetic heart valve may have varying axial lengths. For example, inthe aortic position, a portion of the valve may extend upward into andeven contact the aorta to better stabilize the commissure regions of thevalve. In other words, the particular design of the valve may depend onthe target valve location.

With reference to FIGS. 1 and 2A-2B, an exemplary one-piece prostheticheart valve 20 (complete in FIG. 2A) of the present invention is shown.The valve 20 comprises a stent body 22 that is shown isolated in FIG. 1,and a plurality of leaflet-forming membranes 24. The stent body 22 isshown in both FIGS. 1 and 2A in its expanded configuration generallydefining a tube centered about an axis. The membranes 24 fasten withinthe stent body 22 so as to form a one-way valve therewithin, and orientthe valve to have an inflow end 28 and an outflow end 30. In a preferredembodiment, there are three such membranes 24 each having a free edge 32that extends inward from the stent body 22 and coapts or meets the othertwo free edges generally along radial lines spaced apart 120° withrespect to each other to close the valve during the back flow cycle ofblood flow, as seen in FIG. 2A. When blood flows in the oppositedirection, from the inflow to the outflow end, the free edges 32 of themembranes 24 move radially outward away from each other to open thevalve.

With specific reference to FIG. 1, the tubular stent body 22 comprisesthree sections, starting at the inflow end 28 and moving toward theoutflow end 30: an annulus anchoring section 40, a sinus section 42, andan outflow section 44. The three sections 40, 42, and 44 are desirablyformed from a single generally sheet-like piece of material that can becohesively rolled into a tight spiral and expanded into the tubularconfiguration shown. In this regard, the stent body 22 includes anaxially-oriented first side edge 50 that mates with an axially-orientedsecond side edge 52 along longitudinal seam 53. The two side edges 50,52 abut or overlap and lock together using one or more, preferably twoor more cooperating tabs 54 and slots 56. In the illustrated example,two series of slots 56 a, 56 b are provided around the circumference ofthe stent body 22 adjacent the first side edge 50, while a pair ofengaging tabs 54 a, 54 b are provided adjacent the second side edge 52.

The annulus anchoring section 40 is desirably substantially solid andfree of perforations so as to more reliably retain its tubular shapeupon outward expansion against the native heart valve annulus. In apreferred implantation technique, the prosthetic heart valve 20 expandsoutward and compresses against the native leaflets which present arelatively uneven base. Even if the leaflets are excised, thecircularity of the annulus depends on the skill of the surgeon.Minimizing any openings in the anchoring section 40 enhances itsrigidity so as to ensure a relatively tubular support structure for theleaflet-forming membranes 24. However, anchoring barbs 60 may beprovided in the anchoring section 40, and may be formed by integrallycut tabs as shown. In addition, a pair of openings 62 may be optionallyprovided in the side wall of the tubular stent body 22 to reduce theroll-up stiffness.

With reference to FIG. 2A, the sinus section 42 comprises a plurality(preferably three) of generally axially extending commissures 70 andcurvilinear cusps 72 defined by relatively large sinus apertures 74 inthe stent body 22. In the illustrated embodiment, the sinus apertures 74are generally semi-circular with a straight, circumferential edge 76defined by the beginning of the outflow section 44. A plurality of smallattachment apertures 78 track along the edge of the sinus apertures 74,extending around the curvilinear cusps 72 and substantially up theentire commissures 70.

The membranes 24 fasten to the stent body 22 using the attachmentapertures 78. More particularly, as seen in FIG. 2B, an outer edgeportion 80 of each membrane 24 folds upward in the outflow direction tolie against an inner surface 84 of the stent body 22. This foldedattachment helps reduce localized stresses caused by the sutures throughthe membrane 24, and enhances coaptation of the free edges 32 at thecommissures 70. Fasteners such as sutures 82 secure the outer edgeportion 80 flush against the inner surface 84. The sutures typicallyloop through the membrane 24 twice at each attachment aperture 78 in asingle mattress stitch, though various other stitching techniques areknown. In a preferred embodiment, the attachment apertures 78 are spacedapart a minimum distance of about 0.004-0.0075 inches for strength.

A small lip 86 of the outer edge portion 80 desirably projects beyondthe sinus aperture 74 to help protect the membrane 24 from rubbingdirectly against the material of the stent body 22 during operation ofthe valve. That is, there is membrane-to-membrane cushioned contact atthe sinus apertures 74 when the membranes 24 are forced outward in theopening cycle of the valve. Additionally, all exposed edges of the stentbody 22 are electropolished or coated with a layer of lubriciousmaterial (e.g., PTFE or “TEFLON”) to eliminate any sharp corners andthus reduce wear on the flexible membranes 24.

The free edge 32 of each membrane 24 meets the stent body 22 at one ofthe commissures 70. Because adjacent arrays of attachment apertures 78converge in the outflow direction along each commissures 70, the freeedges 32 of adjacent membranes 24 coapt at or closely adjacent to thestent body inner surface 84, as best seen in FIG. 2A. This configurationeliminates leakage between the free edges 32 when the valve closes.

The outflow section 44 desirably comprises at least a circular band 90of material that joins the outflow ends of the commissures 70. In theillustrated embodiment, the outflow section 44 further includes a secondband 92 axially spaced from the first band 90 and joined thereto with alattice, mesh or grid 94. The outflow section 44 may not be in contactwith any tissue of the heart, but rather project into the respectiveoutflow chamber as a support for the three commissures 70. That is,substantial inward radial loads are imposed on the commissures 70 duringthe closing cycle of the valve, and the outflow section 44 maintains thespacing between the commissures to ensure proper coaptation of themembrane free edges 32. The grid 94 defines more spaces than connectingstruts, and thus minimizes interference with proper blood flows in theoutflow chamber. The outflow section 44 may be rigid, or may be somewhatflexible to mirror aortic wall movement.

In FIG. 2C, an alternative stent body 22′ has a flared outflow section44′ section that conforms to and contacts the aortic wall in an aorticvalve replacement setting. The aortic wall and sinuses diverge outwardfrom the annulus, in which the annulus anchoring section 40′ resides.Therefore, the outward flaring of the outflow section 44′ permitscontact with the aortic wall and better stabilizes the valve in itsimplantation position. Further, the backflow volume on the outflow sideof the leaflets will be slightly increased which may enhance valveclosing. The outflow section 44′ may be formed to spring open to theflared shape, or may be plastically deformed into the flared shape usinga non-cylindrical expansion balloon. For example, the outflow section44′ may be annealed Nitinol that self-expands to the flared shape uponbeing released from within a delivery tube. Further embodiments ofstents having the flared outflow section are shown and described below.

With reference to FIGS. 3A-3C, an exemplary two-piece stent body 100comprises a generally ring-shaped primary stent 102 and a tubularsecondary stent 104 coupled therewithin. The primary stent 102 is shownisolated in FIGS. 4A and 4B and includes a first side edge 106, a secondside edge 108, and a pair of opposed end edges 110 a, 110 b. A pair ofalignment tabs 112 projects radially outward from the end edges 110 a,110 b adjacent the second side edge 108. The alignment tabs 112 provideguides for use during unfurling of the primary stent 102 to maintainconcentricity about a central axis. That is, as the primary stent 102transitions between a first, contracted configuration (i.e., a tightspiral) and a second, expanded configuration, the alignment tabs 112prevent the stent from unrolling to form a cone. Desirably, in thefirst, contracted configuration, the primary stent 102 is spirally-woundabout an axis such that at least one winding of the stent body 100surrounds another winding, and preferably there are numerous windings toreduce the radial profile of the stent 102. Desirably, the second sideedge 108 resides at the center of the tightly rolled secondconfiguration such that as the stent 102 unrolls, the end edges 110 a,110 b slide by and are constrained within the tabs 112. In addition, theprimary stent 102 includes lockout structure in the form of a pair oftabs 114 projecting radially inward near the first side edge 106 and apair of notches 116 in the second side edge 108. The tabs 114 fit withinthe notches 116 and lock the two side edges 106, 108 together.Desirably, a bi-directional locking arrangement is provided to preventcontraction of the stent but also further expansion. There arepreferably two locking tabs/slots along the mating edges, desirablylocated symmetrically about an axial midplane of the stent.

Referring to FIGS. 3A-3C, the secondary stent 104 includes a generallysolid inflow section 120, a sinus section 122, and an outflow band 124.The sinus section 122 is relatively more solid than the sinus section 42of the first embodiment, and includes a plurality, preferably three,oval-shaped sinus apertures 126. A leaflet-forming membrane (not shown)fastens around the inflow edge of each of the sinus apertures 126 insuch a manner so as to coapt within the tubular stent body 100 anddefine the valve occluding surfaces. More specifically, a membranefastening strip 128 follows the edge contour of each membrane with apair of commissure regions 130 and a curvilinear cusp region 132 andprovides an anchor to which the membrane may be attached. The fasteningstrip 128 may be made of pericardium, and may be fastened to the innersurface of the secondary stent 104 using stitching or other suitableexpedient.

In an exemplary embodiment, secondary stent 104 includes at least onelocking tab 140 that projects outwardly through a locking window 142 inthe primary stent 102 to retain the two stents in cooperatingrelationship. The secondary stent 104 includes a first side edge 144 anda second side edge 146 that overlap and are locked together usingsuitable tabs/notches (not further described herein). In use, theprimary stent 102 is first delivered and then unfurled and secured inthe native annulus, after which the secondary stent 104 is delivered andthen unfurled and locked within the primary stent. One or more alignmenttabs 150 may be provided on the secondary stent 104 to engage alignmentslots 152 and ensure the secondary stent unfurls concentrically aroundthe axis. Further, the outwardly projecting alignment tabs 112 andlocking tab(s) 140 may double as anchoring barbs projecting into thenative tissue.

Alternatively, a ratchet type of locking arrangement can be provided forthe primary stent 102 or secondary stent 104 to enable greater sizeadjustment. For instance, multiple engaging teeth may be formed oneither stent 102 or 104 to enable substantially continuous sizeadjustment beyond a minimum annulus diameter. The ratchet teeth may beon circumferentially opposed surfaces or a bent end tab may engage teethprovided on a circumferential edge of the stent. Likewise, couplingstructure between the primary and secondary stents may be used otherthan the tabs/slots shown. For instance, a hook and loop connection maybe realized by expanding the secondary stent within the primary stent.

FIGS. 5A and 5B show in greater detail exemplary alignment tabs/slotsand locking tabs/notches. These figures illustrate an exemplary primarystent having a first side edge 160 and a second side edge 162, althoughthe same concepts may be applied to a secondary stent. A pair ofalignment tabs 164 projects radially outward from the second side edge162 and a second pair of alignment tabs 166 projects radially outwardfrom the body of the stent. A series of circumferential slots 168 areprovided along the length of the stent such that the tabs 164, 166 arereceived therein during the unfurling process. The slots 168 guide thetabs 164, 166 to prevent the stent from unfurling into a cone. Once thestent has fully expanded, a pair of locking tabs 170 projecting radiallyinward from near the first side edge 160 engages a pair of notches 172in the second side edge 162.

FIGS. 6A-6D illustrate a still further primary stent 180 that is similarto, but slightly axially longer than, the primary stent 102 describedabove. Again, the stent 180 includes overlapping first and second sideedges 182 a, 182 b, respectively, and circumferentially disposed endedges 184 a, 184 b. As seen best in FIGS. 6B and 6C, three alignmenttabs 186 project radially outward from the second side edge 182 b intoalignment slots 188. As before, these alignment tabs and slots preventthe primary stent 180 from unfurling unevenly to form a cone. It shouldbe noted that the middle alignment slot 188 is circumferentiallystaggered with respect to the two alignment slots near the end edges 184a, 184 b such that at least one alignment tab 186 resides in one of theslots at all times. Additionally, two pairs of alignment tabs 190project radially outward from the end edges 184 a, 184 b at the secondside edge 182 b, further insuring against misalignment during theunfurling process. A pair of locking tabs 192 projects inward from theprimary stent 102 near the first side edge 182 a and engages acooperating pair of locking notches 194 formed in the second side edge182 b. As can be appreciated from FIG. 6B, the locking tabs 192 andnotches 194 prevent the primary stent 180 from contracting once it hasbeen fully expanded. Finally, FIG. 6D is a detail of an inwardlydirected coupling tab 196 that may be used to couple a secondary stentto the primary stent 180. In the illustrate embodiment, there are threesuch coupling tabs 196 distributed evenly about the stent.

FIG. 7 illustrates a secondary stent 200 of the present invention inplan view, before being rolled into its contracted configuration. Thestent 200 has a generally rectangular periphery defined by a first sideedge 202 a, a second side edge 202 b, and a pair of linear end edges 204a, 204 b. Again, the secondary stent 200 comprises a generallysheet-like body that can be rolled into a relatively tight configurationand unrolled into a tube. Three sinus apertures 206 a, 206 b, 206 cformed in the secondary stent 200 each having a curvilinear cusp 208 anda pair of generally linear commissures 210 of either side of the cusp.The commissures 210 are joined by an outflow band 212. A pair ofcombined alignment and locking tabs 216 is sized to translate withinrespective alignment slots 218 to insure even unfurling of stent 200. Apair of locking notches 220 is formed at the end of the alignment slots218 closest to the first side edge 202 a. The locking tabs 216 have anenlarged head joined by a neck to the body of the stent 200 and thelocking notches 220 also include a tapered neck 222 that permits passageof the tab neck in only one direction so as to lock it therein.

FIG. 8 is a detailed isolation of overlapping side edges of a secondarystent showing alignment tabs 230 disposed on side edges of the innerlayer of the stent. These alignment tabs 230 therefore can replace thealignment tabs 216 and slots 218 of the secondary stent 200 of FIG. 7,although alternative locking structure must be provided.

FIG. 9 illustrates a still further secondary stent 250 of the presentinvention, and FIG. 10 illustrates the same stent coupled with theprimary stent 180 of FIG. 6A. The secondary stent 250 includes many ofthe same features described above, including a generally solid inflowsection 252, a sinus section 254, and an outflow band 256 (again, theleaflet-forming membranes are not shown to better illustrate the stent).The body of the stent 250 includes two pairs of side alignment tabs 258that prevent the stent 250 from unfurling into a conical form. One ormore lockout tabs 260 extend outward from one side edge of the stent 250and engage one or more apertures 262 in the other side edge to securethe edges in an overlapping relationship as shown. A plurality ofcoupling windows 264 is located at evenly-spaced circumferentialintervals around the body of the stent 250 to receive and retaincoupling tabs 196 extending inward from the primary stent 180 (see FIG.6D). Note in FIG. 10 that the alignment tabs 258 closely conform to theinflow end of the primary stent 180 and further help retain the stentassembly together. Also, these alignment tabs 258 may serve as anchoringbarbs to retain the valve in the host annulus.

FIGS. 11A-11E illustrate another primary stent 270 that features aplurality (at least three) of outwardly angled anchoring spikes 272. Thestent 270 includes a band-like body 274 having a first side edge 276 aand a second side edge 276 b, with opposed and parallel end edges 278 a,278 b extending therebetween. The anchoring spikes 272 extend axiallyaway and then radially outward from the respective end edges 278 a, 278b a distance of between about 1-2 mm. There are desirably at least threeanchoring spikes 272 extending from each end edge 278 a, 278 b, and morepreferably six. In addition, a plurality of body anchoring barbs 280 isdisposed at regular intervals around the body 274. These barbs 280 maybe small portions of the body 174 stamped into spikes and bent outwardfrom the body 274. The barbs 280 desirably have a length of about 1 mm.FIGS. 11B and 11C illustrate a two-way lockout structure on the sideedges 276 a, 276 b including tabs 282 and receptacles 284. In addition,alignment tabs 286 and slots 288 are provided as described above.

FIG. 12 shows the primary stent 270 of FIGS. 11A-11E coupled to analternative secondary stent 290. The secondary stent 290 has relativelylarge, semi-circular sinus apertures 292 and membrane attachment strips294 on its inner surface. Note that the sinus apertures 292 have acurvilinear cusp edge 296 that coincides approximately with an end edge278 b of the primary stent 270. This maximizes exterior reinforcementfor the secondary stent 290 without interfering with the motion of theleaflet-forming membranes (not shown).

FIGS. 13A-13C schematically illustrate a secondary stent 300 unfurlingwithin a primary stent 302. The primary stent 302 includes coupling tabs304 bent inward from the body of the stent that have an axially-openingnotch 306 on one side. The tabs 304 are slightly circumferentiallyoffset with respect to one another, and axially spaced nearly the entireaxial dimension of the primary stent 302. As best seen in FIG. 13C, thesecondary stent 300 has a pair of V-shaped slots 308 located on a firstside edge 310 that couple with the tabs 304. More specifically, theslots 308 terminate in a bridge 312 between the slot and a cutout 314,and the coupling tab 304 is designed to frictionally engage the bridgeby virtue of the shape of the notch 306. The first side edge 310 is thusunrolled and the tabs 304 coupled to the slots 308 by a relative axialdisplacement of the secondary stent 300 and primary stent 302. Oncecoupled, the secondary stent 300 is fully unfurled and locked in itsexpanded configuration within the primary stent 302. The secondary stent300 may be coupled to the primary stent 302 using relative axial and/orcircumferential motion with or without a tactile feedback signalingcompletion of the coupling operation.

FIGS. 14-18 illustrate various steps in the process of rolling a primarystent of the present invention (i.e., converting a flat sheet-likematerial into the first, contracted configuration of the stent). Arolling base 320 includes a raised rolling platform 322 surrounded by apair of linear rolling tracks 324. A stent roller 326 includes a centralmandrel 328 and a pair of rolling wheels 330 that ride within the tracks324.

An initially flat sheet-like primary stent 334 is placed on the rollingplatform 322 and secured thereto at a first side edge 336. FIG. 15Cillustrates one means for securing the first side edge 336, that is,angled pins 338 through holes in the first end. Alternatively, a clamp340 as seen in FIG. 16 may be tightened over the first side edge 336.

With reference to FIGS. 15A and 15B, the stent roller 326 is temporarilysecured to a second side edge using a pin 342 aligned with the mandrel328. A plurality of lockout tabs 344 are seen projecting between the pin342 and the mandrel 328 such that rotation of the roller 326 lifts thesecond side edge upward from the platform 322. The pin 342 extendsthrough a small cavity in both rolling wheels 330 adjacent the mandrel328 and may be easily removed once the rolling operation is complete.

FIG. 17A shows the stent 334 in its rolled configuration after the stentroller 326 has translated the length of the rolling platform 322. Therolling tracks 324 are slightly ramped upward toward the platform 322 toaccommodate the gradually increasing diameter of the stent 334 as it isrolled. A plurality of linear grooves 350 in the rolling platform 322provide clearance for any radially outwardly projecting tabs on thestent 334. FIG. 17B shows a suture 352 or other such retaining meanstied around the rolled stent 334 to enable removal of the stent androller 326 from the platform 322.

Finally, FIGS. 18A and 18B schematically illustrate the steps forremoving the rolled stent 334 from the roller 326. Specifically, one ofthe wheels 330 is removable and the rolled stent 334 is then freed foruse. The inner bore illustrated may be substantially smaller if asmaller mandrel 328 is used. The same sequence of rolling may be usedfor both the primary and secondary stents with the membranes. Themembranes lie relatively flat against the secondary stents and presentlittle obstacle to rolling.

The rolled stent 334 desirably has a diameter of less than about 20 mm.An aspect ratio of the stents of the present invention may be defined asthe axial length over the final, expanded diameter. Some of the primarystents as described above may have a relatively small aspect ratio,desirably less than about 2.

Once the rolled stent 334 is formed, it is loaded within a delivery tubeor catheter and urged down the tube to the implantation site (of course,the suture 352 will be removed). A pusher or other such device may beused to advance the rolled stent 334. Once at the site, the tube may beretracted and the rolled stent 334 caused to unfurl on its own, thestent may be delivered over an inflation balloon to enable plasticdeformation/expansion, or the stent may be expanded with a subsequentlyintroduced balloon or mechanical expander.

FIG. 19 illustrates a still further one-piece expandable heart valvestent 400 of the present invention in its flattened configuration havinga somewhat more solid or robust outflow section 402 than shownpreviously coupled to a sinus section 404 and anchoring section 406 onthe inflow end of the stent. The stent 400 comprises a single sheet-likebody 408 of a rolled superelastic metal alloy, preferably Nitinol. Fororientation purpose, the body 408 is initially formed in the Y-Z planeas shown, and is elongated in the Y direction with a generallyrectangular outline. The body 408 is designed to be rolled up on itselfabout a Z-axis into a relatively tight spiral, and later unrolled toform a tube with a first side edge 410 a connecting to a second sideedge 410 b. In the illustrated embodiment, the left side of the stentbody 408 forms the inner winding of the spiral while the right side isthe outer winding. Desirably, and as mentioned above, the first sideedge 410 a and second side edge 410 b overlap in the enlarged tubularconfiguration. The body 408 also defines relatively linear first andsecond end edges 412 a, 412 b that form the circular outflow and inflowrims, respectively, of the tubular stent.

The stent 400 includes alignment structure for ensuring proper unrollingabout the central Z-axis, and also locking structure for maintaining thefinal tubular shape. Specifically, a pair of guide/lockout tabs 414 a,414 b engage a guide slot 416 that extends along the Y-axis in theoutflow section, closely adjacent the sinus section 404. A single suchguide slot 416 as shown located generally in the center of the body 408with respect to the Z-axis is believed sufficient to hold the stent inthe final tubular shape, although two or more may be used as describedpreviously. The guide/lockout tabs 414 a, 414 b each include an enlargedgenerally semi-circular head 418 and a narrow neck 420 connecting thehead to the body 408. A first tab 414 a extends from the first end edge410 a while a cutout in a mid-portion of the body 408 forms a second tab414 b.

The spaced tabs 414 a, 414 b align with the guide slot 416 and areannealed out of the plane of the body 408 so as to fit within the slot.Specifically, the tabs 414 a, 414 b are annealed so that they bendinward with respect to the rolled spiral of the stent body 408 and canthen be introduced into the slot 416. Once in the slot 416, the head 418of each tab 414 a, 414 b projects through to the outside of the body 408and retains the tabs in engagement with the slot. The neck 420 has awidth that is slightly smaller than the slot width for easy longitudinalmovement therewithin. As the stent body 408 unfurls from its tightlycoiled contracted state to its expanded state, the tabs 414 a, 414 btravel along the slot 416 (from the left to the right in the drawing).As this process occurs, the maintenance of the tabs 414 a, 414 b withinthe slot 416 ensures that the stent body 408 will not misalign andunroll into a conical shape. Ultimately, the tabs 414 a, 414 b travelpast two pairs of similarly spaced lockout notches 422 annealed out ofthe plane of the body 408 toward the inside of the now tubular stent.The interference between these lockout notches 422 and the heads 418 ofthe tabs 414 a, 414 b retains the stent 400 in its open, expandedconfiguration.

A plurality of engaging pairs of bridge tabs 424 and apertures 426maintain a uniform width of the guide slot 416 to retain the tabs 414 a,414 b therein during unrolling of the stent body 408. Each tab 424 isannealed so as to bend and lock into the corresponding aperture 426.Maintenance of the guide slot 416 width ensures a continuous engagementof the tabs 414 a, 414 b and guide slot 416 during the unrollingprocess.

The stent body 408 further includes a plurality of edge tabs 430 locatedalong both end edges 412 a, 412 b adjacent the first side edge 410 a.Although shown flattened in the plane of the stent body 408, the edgetabs 430 are also annealed to bend generally perpendicular to the stentbody. The edge tabs 430 are disposed closely to and constrain the endedges 412 a, 412 b during the unrolling process to further help preventmisalignment. A pair of stop slots 432 is formed in the anchor section406 to limit the extent that the stent body 408 unrolls. One side ofeach slot 432 is annealed out of the plane of the stent body 408 so thatthey engage each other after the body has unrolled to the tubular finalshape.

The outflow section 402 includes an array of diamond-shaped apertures434 forming an open lattice, mesh or grid pattern that reduces the stentsurface area and thus the risk of thrombosis after implantation. Theopen mesh pattern is somewhat stiffer than, for example, the gridpattern shown in the stent of FIG. 1, and helps stabilize the valvecommissures 440 about which flexible leaflet membranes 442 (shown inphantom) are attached. A plurality of triangular-shaped cutouts 444aligned in the Y-direction in the outflow section 402 “ratchet” againstone another during unrolling of the stent body 408 and thusincrementally prevent closing of the stent.

Still with reference to FIG. 19, the sinus section 404 incorporatesthree membrane apertures 450 defining the aforementioned commissures 440and intermediate curvilinear cusps 452. A series of attachment holes 454closely surrounds each aperture 450 and is used to suture or otherwiseattach each membrane 442 to the stent 400. The edge of each membrane 442is folded as described above with respect to FIG. 2B to help preventwear and ensure longevity. The opposed ends of the sinus section 404 areshaped to conform to the outer two membrane apertures 450. That is, apair of opposed extension flaps 456 a, 456 b on the anchoring section406 overlap and each blends along a curvilinear edge 458 a, 458 b towardthe outflow section 402. These curvilinear edges 458 a, 458 b providereliefs to avoid occluding either of the outer two membrane apertures450 when the stent is locked open and the flaps 456 a, 456 b overlap.

Although not shown, a plurality of anchoring barbs are desirablyprovided in at least the anchoring section 406 to secure the unrolledvalve into position in the valve annulus and aortic root. Further, theoutflow section 402 may be annealed so as to flare outward and contactthe ascending aorta for further anchoring.

FIG. 20A illustrates a still further one-piece expandable heart valvestent 500 of the present invention in its flattened configuration withan outflow section 502 coupled to a sinus section 504 and anchoringsection 506 on the inflow end of the stent. The stent 500 againcomprises a single sheet-like body 508 of a rolled superelastic metalalloy, preferably Nitinol. For orientation purpose, the body 508 isinitially formed in the Y-Z plane as shown, and is elongated in the Ydirection with a generally rectangular outline. The body 508 is designedto be rolled up on itself about a Z-axis into a relatively tight spiral,and later unrolled to form a tube with a first side edge 510 aconnecting to a second side edge 510 b. In the illustrated embodiment,the left side of the stent body 508 forms the inner winding of thespiral while the right side is the outer winding. That is, the stentbody 508 is rolled from the left end in the direction of arrow 511.Desirably, the first side edge 510 a and second side edge 510 b overlapin the enlarged tubular configuration. The body 508 also defines firstand second end edges 512 a, 512 b that form the circular outflow andinflow ends, respectively, of the tubular stent.

The stent 500 includes alignment structure for ensuring proper unrollingabout the central Z-axis, and also locking structure for maintaining thefinal tubular shape. Specifically, guide/lockout tabs 514 a, 514 bengage guide slots 516 a, 516 b aligned therewith along the Y-axis. Afirst pair of tab 514 a and slot 516 a is located in the outflowsection, closely adjacent the sinus section 504, while a second pair oftab 514 b and slot 516 b is located in the anchoring section, closelyadjacent the second end edge 512 b. The guide/lockout tabs 514 a, 514 bare each formed with an enlarged head 518 and a pair of necks 520 oneither side of the head connecting it to the body 508. Each head 518 isannealed to bend about the necks 520 out of the plane of the stent body508 and fits through an entrance opening 522 into the respective slot516. In the illustrated embodiment, the heads 518 are bent out of thepage and the stent body 508 is rolled about the Z-axis out of the pageso that the heads 518 project radially outwardly through the entranceopenings 522.

As seen in FIGS. 20A and 20B, each slot 516 includes a pair of lockouttabs 524 near the slot end closest to the second end edge 510 b. Smallangled cutouts 526 diverging on either side of the slot 516 form thelockout tabs 524. Each tab 524 is annealed to bend out of the plane ofthe stent body 508, in this case into the page. As the stent body 508unrolls, the heads 518 of the tabs 514 a, 514 b slide from left to rightalong the slots 516 and cam over the bent tabs 524. The tabs 514 a, 514b are thus prevented by the tabs 524 from retreating along the slots 516a, 516 b. The maintenance of the tabs 514 a, 514 b within the slots 516a, 516 b ensures that the stent body 508 will not misalign and unrollinto a conical shape.

A plurality of bridges 528 maintains a uniform width of the guide slots516 a, 516 b to retain the tabs 514 a, 514 b therein during unrolling ofthe stent body 508. Each bridge 528 crosses over the respective slot 516a, 516 b and is secured thereto at points 530, such as by ultrasonicwelding. Alternatively, bridges formed as an integral part of the stentbody 508 are contemplated. Maintenance of the guide slot 516 widthensures a continuous engagement of the tabs 514 a, 514 b and guide slots516 a, 516 b during the unrolling process. The bridges 528 are locatedon the inner side of the stent 508 in its rolled configuration.

The outflow section 502 includes an array of cross members 534 forming alattice, mesh or grid pattern with diamond-shaped openings that reducesthe stent surface area and thus the risk of thrombosis afterimplantation. Adjacent the mesh pattern, a solid band 536 of the stentbody 508 within which the guide slot 516 a is formed helps stabilize thevalve commissures 540 about which flexible leaflet membranes 542 (shownin phantom) are attached.

Still with reference to FIG. 20A, the sinus section 504 incorporatesthree membrane apertures 550 defining the aforementioned commissures 540and intermediate curvilinear cusps 552. A series of attachment holes 554closely surrounds each aperture 550 and is used to suture or otherwiseattach each membrane 542 to the stent 500. The edge of each membrane 542is folded as described above with respect to FIG. 2B to help preventwear and ensure longevity. The right end of the sinus section 504 isshaped to conform to the left membrane apertures 550. That is, acurvilinear edge 558 provides a relief to avoid occluding the leftmembrane aperture 550 when the stent is locked open and the end edges510 a, 510 b overlap.

Although not shown, a plurality of anchoring barbs are desirablyprovided in at least the anchoring section 506 to secure the unrolledvalve into position in the valve annulus and aortic root. Further, theoutflow section 502 may be annealed so as to flare outward and contactthe ascending aorta for further anchoring.

FIGS. 21A illustrates a heart valve 600 of the present invention havinga stent 602 similar to the stent 500 described above with reference toFIG. 20A. A pair of lockout/guide tabs 604 a, 604 b engages an alignedpair of guide slots 604 a, 604 b to both ensure proper unrolling andsecure the unrolled valve in its expanded configuration. The tabs 604 a,604 b and slots 606 a, 606 b may be configured as described above withrespect to either of the embodiments of FIG. 19 or 20A, or may be asimilar expedient. In this regard, entrance openings 608 and lockouttabs 610 may be provided to enable the tabs 604 a, 604 b to enter theslots 606 a, 606 b and be retained therein in an open, unrolledconfiguration of the valve 600. A plurality of bridges 612 seen on theinside of the stent 602 through the slots 606 a, 606 b maintain thewidth of the slots as described above.

The stent 602 includes an outflow section 620 having a mesh 622 that isannealed to flare outward into contact with the aorta and increase thestiffness of valve commissures in a sinus section 624. The sinus section624 includes three membranes 626 attached around generally semi-circularapertures 628 to form the occluding surfaces of the valve when fullyunrolled.

FIG. 21B illustrates the stent 602 by itself in a partial state ofunrolling, while FIG. 21C shows the stent fully unrolled. Note theflared configuration of the mesh 622 on the outflow section 620 and theoverlapped sides of the stent.

FIGS. 22 and 23 illustrate two different two-piece expandable heartvalve stents that are coupled using guide wires. In FIG. 22, a generallytubular primary stent 700 is first unrolled and implanted in the body. Asecondary stent 702 of various configurations described above is thendelivered in its contracted state into proximity with the primary stent700 and unrolled and coupled thereto. To ensure proper rotationalalignment between the primary stent 700 and secondary stent 702, aplurality of guide wires 704 are threaded through features (not shown)within the secondary stent 702 and coupled to corresponding features onthe primary stent 700. For example, the guide wires 704 may be threadedor otherwise registered with coupling tabs (not shown) on the secondarystent 702 and also with coupling apertures 706 on the primary stent 700.In this way, the secondary stent 702 advances along the guide wires 704and is rotationally oriented thereby to ensure mating engagement of thecoupling features. The distal end of a delivery tube 708 is illustratedthrough which the guide wires 704 are pulled.

FIG. 23 likewise shows a generally tubular primary stent 720 beingcoupled to a secondary stent 722 using a plurality of guide wires 724.The secondary stent 722 includes a tubular mesh portion 726 and ascalloped wireform portion 728 on an outflow end. Although not shown,the wireform portion 728 receives valve leaflets or an intactbioprosthetic valve as is well known in the art. The tubular meshportion 726 fits within and couples to the tubular primary stent 720,while the wireform portion 728 remains completely or substantiallycompletely extended out of the outflow end of the primary stent. Again,the distal end of a delivery tube 730 is illustrated.

The heart valves of the present invention may be implanted using severalminimally-invasive approaches, and in one or more stages. For example,the single stent valves described herein may be delivered using a pusheror along with a balloon catheter through a large bore cannula orcatheter (i.e., tube). The two piece valves may be delivered through asingle tube, or through two different tubes in sequence. In oneembodiment, the stent having the flexible membranes thereon may bestored in an unfurled configuration to reduce stress on and damage tothe membranes, and rolled into a compact tube just prior to use. One ortwo balloons may be used, or the stents can be primarily self-expandingwith a balloon or other expansion device used to provide a finaldeployment force, such as for anchoring barbs in the annulus or lockingthe rolled stents in the open configuration.

While the foregoing describes the preferred embodiments of theinvention, various alternatives, modifications, and equivalents may beused. Moreover, it will be obvious that certain other modifications maybe practiced within the scope of the appended claims.

1. A percutaneously deployable prosthetic aortic valve for replacing adamaged or diseased native aortic valve, the prosthetic heart valvecomprising: an axial axis, an inflow end, and an outflow end; anexpandable, tubular stent body comprising a wall defining an interiorand an exterior of the stent body, the wall of the stent bodycomprising, from the inflow end to the outflow end of the prostheticvalve, an annulus anchoring section, a sinus section, and an outflowsection, the sinus section of the wall of the stent body comprising aplurality of apertures dimensioned to permit blood flow therethrough,and the outflow section of the wall comprising at least one of anapertured lattice, a mesh, and a grid pattern; and a valve structuredisposed within the interior sinus section of the stent body wall, thevalve structure having an open state permitting blood flow from theinflow end to the outflow end of the prosthetic valve, and a closedstate preventing blood flow from the outflow end to the inflow end ofthe prosthetic valve, the valve structure comprising three pericardiummembrane leaflets, each leaflet comprising a free edge and a curvedouter edge, the free edges of the leaflets dimensioned to coapt when thevalve structure is in the closed state, the free edges of the leafletsmeet the stent body at commissures, and the outer edges of the leafletssutured to the sinus section of the stent body; wherein the prostheticvalve has a contracted configuration and a expanded configuration, inthe expanded configuration, the outflow section of the stent body wallis flared outward from the sinus section, the flared outflow section ofthe stent body wall is dimensioned to contact an ascending aorta abovethe native heart valve, and the annulus anchoring section of the stentbody wall is dimensioned to engage an annulus of the native aorticvalve, and in the contracted configuration, the prosthetic valve isdimensioned for percutaneous delivery.
 2. The prosthetic heart valve ofclaim 1, wherein the stent body is self-expanding.
 3. The prostheticheart valve of claim 2, wherein the wall of the stent body comprisesnitinol.
 4. The prosthetic heart valve of claim 2, wherein the wall ofthe stent body is a one-piece wall.
 5. The prosthetic heart valve ofclaim 1, wherein, in the contracted configuration, the stent body isrolled axially.
 6. The prosthetic heart valve of claim 5, wherein thestent body comprises a first side edge and a second side edge, the firstside edge and the second side edge extending axially, and the first sideedge mating with the second side edge in the expanded configuration. 7.The prosthetic heart valve of claim 6, wherein the first edge and secondedge of the stent body comprise corresponding tabs and slots that engageeach other in the expanded configuration.
 8. The prosthetic heart valveof claim 1, wherein the annulus anchoring section of the wall of stentbody is substantially solid.
 9. The prosthetic heart valve of claim 1,wherein the valve leaflets comprise at least one of porcine and bovinepericardium.
 10. The prosthetic heart valve of claim 1, wherein thecurved edge of each leaflet is substantially semi-circular.
 11. Theprosthetic heart valve of claim 1, wherein the sinus portion of the wallof the stent body further comprises a plurality of attachment aperturesthrough which the leaflets of the valve structure are sutured.
 12. Theprosthetic heart valve of claim 1, wherein a diameter of the prostheticvalve in the contracted configuration is less than about 20 mm.
 13. Ansystem for replacing a damaged or diseased native aortic heart valve,the system comprising: the prosthetic heart valve of claim 1; and acatheter or delivery tube dimensioned for percutaneous access of anative aortic valve, the catheter or delivery tube comprising a lumendimensioned to receive the prosthetic heart valve in the contractedconfiguration.
 14. The system of claim 13, further comprising a pusherdimensioned to advance the prosthetic heart valve in the contractedconfiguration through the lumen of the catheter or delivery tube. 15.The system of claim 13, further comprising an expansion balloon having adeflated state and an inflated state, the expansion balloon in thedeflated state dimensioned to carry the prosthetic heart valve in thecontracted configuration, and the expansion balloon in the inflatedstate dimensioned to convert the prosthetic heart valve carried thereoninto the expanded configuration.
 16. A percutaneously deployableprosthetic aortic valve for replacing a damaged or diseased nativeaortic valve, the prosthetic heart valve comprising: an axial axis, aninflow end, and an outflow end; an self-expanding, tubular stent bodycomprising a one-piece, nitinol wall defining an interior and anexterior of the stent body, the wall of the stent body comprising, fromthe inflow end to the outflow end of the prosthetic valve, an annulusanchoring section, a sinus section, and an outflow section, the sinussection of the wall of the stent body comprising a plurality ofapertures dimensioned to permit blood flow therethrough, and the outflowsection of the wall comprising at least one of an apertured lattice, amesh, and a grid pattern; and a valve structure disposed within theinterior sinus section of the stent body wall, the valve structurehaving an open state permitting blood flow from the inflow end to theoutflow end of the prosthetic valve, and a closed state preventing bloodflow from the outflow end to the inflow end of the prosthetic valve, thevalve structure comprising three porcine pericardium membrane leaflets,each leaflet comprising a free edge and a curved outer edge, the freeedges of the leaflets dimensioned to coapt when the valve structure isin the closed state, the free edges of the leaflets meet the stent bodyat commissures, and the outer edges of the leaflets sutured to the sinussection of the stent body wall; wherein the prosthetic valve has acontracted configuration and a expanded configuration, in the expandedconfiguration, the outflow section of the stent body wall is flaredoutward from the sinus section, the flared outflow section of the stentbody wall is dimensioned to contact an ascending aorta above the nativeheart valve, and the annulus anchoring section of the stent body wall isdimensioned to engage an annulus of the native aortic valve, and in thecontracted configuration, the prosthetic valve is dimensioned forpercutaneous delivery.